Yaz, Yasmin, Ocella Side Effects Lawsuit News

FDA advisory panel recommends stronger warning for drospirenone-containing birth control

- Modern Medicine

12/16/2011 - An FDA advisory panel has recommended that some oral contraceptives may need stronger warning labels, according to recent reports.

The day-long joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of FDA was to involve discussion on the risks and benefits of drospirenone-containing birth control pills because of emerging safety concerns over the potentially higher risk of venous thromboembolism associated with these drugs compared with levonorgestrel-containing drugs, according to FDA meeting materials.

The committee heard testimony on research results from Bayer HealthCare Pharmaceuticals, the manufacturer of a family of drospirenone-containing birth control pills, including Yaz and Yasmin. Research results presented by Bayer demonstrated no increased risk of blood clots, which conflicted with other studies that found evidence that drospirenone was associated with higher risk of blood clot formation.

Although 15 of FDA's 26 expert advisors voted that the benefits of these birth control pills outweighed the risk of blood clots, 21 of the 26 panelists voted that the current labels for Bayer's drospirenone-containing combination oral contraceptives do not adequately reflect the products’ risk benefit profile and should be revised to include additional information from available studies, said a statement from Bayer.

In September, FDA released a statement informing the public that it remained concerned about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. The agency scheduled the meeting after several studies demonstrated conflicting results.

Bayer HealthCare Pharmaceuticals Vice President and Head of US Medical Affairs Pamela A. Cyrus, MD, said, "We thank the Committee members for their efforts and participation in the discussion on the benefit-risk profile for drospirenone-containing combination oral contraceptives.” The company added that it will continue to work with FDA and other regulatory authorities to make label updates as appropriate.

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